Counterfeit medicine is a significant problem, in India as well as globally. While the scope and definition of the problem differ, there is no debate over the pressing need to take preventive actions for combating counterfeit medicines and protecting the lives of millions of consumers. According to a FICCI committee report, counterfeit drugs make up to 15-20 per cent of the market.
Didier Lacroix Global Senior Vice President – Sales & Mktg., Cognex |
Didier Lacroix, Global Senior Vice President – Sales and Marketing), Cognex states, “It is difficult to estimate the seriousness of the problem of drug counterfeits in India. There is a possibility that more than 25 per cent of the medicines consumed in the poor or developing countries could be counterfeit. The extent of counterfeit medicines is difficult to obtain as there are no global specific studies on them as of now. The various numbers can only be known from organisations like WHO and drug regulatory authorities implementing various policies to counter drug counterfeiting.”
The Indian Government estimated that about 0.4 per cent of the country’s drugs are counterfeit and that substandard drugs account for about eight per cent. But independent estimates range from 12 to 25 per cent with poor traceability of medicinal packages playing a key role in the growth of fake drugs across the country. Hence, tracking and tracing of individual pharma packages as well as an entire export pallet using a high-end bar coding mechanism is an important tool in fighting drug counterfeiting in India.
Notification in place
The Indian government is taking effective measures to counter proliferation of spurious drugs within India and is also working towards curbing the exports of counterfeit drugs. Recently, the task force for the Union Ministry of Health recommended SMS authentication as the ideal solution to protect medicines meant for sales within the country.
On the export side, the Directorate General of Foreign Trade (DGFT) notification of October 2011 (see article ‘Decoding the barcode’, Express Pharma, October 16-31, 2011) has been an important step in taking preventive measures to protect drugs.
Additionally, packaging machines currently available also cater to other, non-pharma industries. Packaging technology should evolve to create smaller, more cost-effective machines that can cater specifically to pharma companies’ needs. Such machines should consider both the budget of large pharma companies as well as small and medium enterprises, whose products make up a large portion of ‘Brand India pharma’.
| Fake drugs have two types of effects |
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IATA PCR from July 1
Another interesting change in healthcare packaging is the mandated requirement for the transportation of time and temperature sensitive health cargo shipments. The air cargo industry is using IATA Perishable Cargo Regulations (PCR) as an essential reference guide for all those stakeholders involved in the packaging and handling of perishables for air transport.
Based on the recommendation of the Time and Temperature Task force and working group members and endorsed by the IATA Live Animals and Perishables Board, the IATA Time and Temperature Sensitive labels became mandatory for the transportation of the health cargo shipments from July 1 this year
Ashifi Gogo Chief Executive Officer, Sproxil |
Ashifi Gogo, Chief Executive Officer, Sproxil says, “Government could encourage adoption of such machines from statutory taxes for the initial few months and incentivise pharma companies to comply with the mandate as per the deadline.”
Types of track and trace systemsSMS authentication service is one of the best ways for a consumer to know if the product purchased is genuine or fake. Sproxil offers this SMS authentication service for both pharma and non-pharma products. By using technology already highly prevalent in developing markets, Sproxil’s mobile product authentication (MPA) solution empowers consumers to actively avoid counterfeits and only purchase genuine products through their mobile phone.
Track and trace technology has helped various companies protect their product and assured consumers that the medicines they are consuming are reliable and safe. It is the need of hour that technologies like this should be made mandatory for pharma companies so that it can assist them in tracking fake medicines within the country and ensure patients that they are safe from illegal drugs existing in the market. The proposed track and trace technology is capable of tracking the drugs right from the manufacturers to the retailers to check the threat of counterfeiting of drugs in the country.
The rules are in place but industry uptake of these solutions has been poor. Lacroix informs, “Not more than 10 per cent of companies have implemented this system in their organisation. Government needs to take a major action and implement a hard and fast rule to install this system within the mentioned deadline. Only few top companies have implemented this system in their organisation. “
Kishore Kar VP – Sales & Mktg., PharmaSecure |
Kishore Kar, Vice President-Sales and Marketing, PharmaSecure highlights,“The DGFT notification is a welcome move by the industry as it is an attempt to standardise security mechanisms across the industry. Many of our customers have already complied with these standards, taking the necessary moves to implement the system.”
No doubt the system change presents challenges. As Kar reveals, “Implementation of any new notification takes time at the operational level. The manufacturers have to make the necessary hardware arrangements to comply with the change.”
Lacroix says, “The recent recommendations of the task force on track and trace is a great step to detect counterfeit drugs before they go for sale. Cognex’s In-Sight Track & Trace works with networked in-sight vision systems to create a complete identification and data verification solution for labels on pharma packaging.”
Kar explains,“The implementation of primary packaging is on target. Primary level packaging is more challenging and takes more time for the industry to fully implement than tertiary and secondary. We started primary level coding with SMS authentication in 2010 and are continually seeing the market expand. Reaction from all stakeholders across the industry has been very positive to our solutions for the simple reason that our mobile authentication system is backed by a very strong and secure back-end. Its simplicity, scalability and smooth integration with a variety of manufacturing systems make the association with our clients highly valuable.”
Describing the salient features of PharmaSecure’s solutions from a patient/ consumer point of view, Kar says, that as a SMS authentication solution it is a consumer-centric solution that empowers consumers to authenticate their products. “Ease of mobile usage, and quick response time guarantees convenience and limited time consumption thereby making the solution extremely user friendly,” sums up Kar.
Lack of clarity adds to challenges
The DGFT’s intent to help protect Brand India from the impact of the counterfeiters, led it to implement new barcoding measures after a thorough review of the measures suggested by the different stakeholders of the pharma business.
However, without clear direction on the use of these barcodes (like for consumers to validate products or to prevent reimbursement fraud), there is a lot of apprehension surrounding the use of barcodes on product packaging.
Further, many critics of the mandate are of the opinion that barcodes alone will not be able to hinder the increase of spurious drugs in the market. The lack of barcode readers, computers and point of sale (PoS) systems at all points of the supply chain significantly cripple the commercial overall value derived from implementing the DGFT barcode mandate. The barcodes are meant to create a more robust track and trace system, but if there are not enough scanners to document information on products moving down the supply chain, the system remains flawed.
Finally, unreliable infrastructure characteristics of developing countries such as irregular internet connectivity and unreliable power (if available at all) poses another major challenge to the barcode solution.
According to Gogo, the changes needed to implement the mandated barcode solution at the secondary and primary levels can have high cost implications depending on the way the solution is implemented. For complicated or sub-optimal manufacturing plants, implementation is currently not easy for the SME’s given their oft-limited budgets for technology adoption. He further highlights that the government’s role should be to facilitate and encourage adoption of a consumer-level SMS authentication service. It should set standards for the service providers to sell their solutions to the industry and facilitate healthy competition for private players already established in this field. In return, service providers can provide valuable market information collected from their databases and report to the authorities immediately of any anomalies or suspicious activity.
Many of India’s small and medium scale pharma enterprises are challenged to keep up with the technological complexities and the implementation costs. Some of the large Indian pharma organisations are also apprehensive about the impact that the barcode implementation will have on their high-speed manufacturing lines. New affordable printing technologies have to be developed to keep up with the pace of barcoding innovation.
So far, implementing DGFT norms of compliance at the tertiary packaging (shipper) level has not been much of a problem, mainly because of the much slower packaging speeds and fewer units to be labelled at this level. However, with so many issues still unresolved some stakeholders are now adopting a ‘wait and see’ approach especially since the entire barcoding exercise was halted by the Chennai High Court in December 2011. As the July 1 deadline came and went, the decision is still pending, and industry continues to be in limbo. On one hand, the Chennai Court’s stay has brought relief to industry players, especially SME players, but for how long?
Invest for future growth
At the expected growth pace, Indian packaging industry will soon climb up to the fourth position in the world packaging industry. India has an enormous economic, topographic and social diversity that provides a major challenge to provide pharma products with the requisite safely and security, while being cost effective at the same time.
Kar says, “The government initiative is strategic in two ways: first, the ‘Made in India’ brand is protected from counterfeiters; and second, globally the industry is moving in the direction of serialisation and track and trace systems. Serialisation is a widely prevalent authentication measure being used across the globe and this notification will help Indian manufacturers comply with global standards.”
He makes the point that enhanced security mechanisms strengthen the confidence levels of foreign players sourcing from India. India is known as a major global player in drug manufacturing. In 2010, India’s pharma industry was worth $10 billion and ranked 15th globally, according to IMS Health. Inbuilt counterfeit control mechanisms such as coding of primary, secondary and tertiary drug packaging ensures a high level of security and global compliance for domestic Indian manufacturers, emphasises Kar.
Gogo too alludes to the benefits of investing in such technologies, advising, “To compete with the international brands, the Indian packaging industry must utilise unique collaborations or in-house development of technologies such as UIDs with mobile phone based consumer verification technology to curtail counterfeits.”
The future clearly lies in a unified system that allows both track and trace as well as consumer authentication. Thus it is high time that industry players accept the fact that some form of authentication will need to be deployed and plan their budgets accordingly.